Customer stories
How pharma, biotech, CDMO, and CGT teams reshaped their validation and inspection workflows with cGen.
Mid-size pharma · Boston, MA
Outcome
Inspection-ready inventory built in 4 weeks. Last FDA walk-in lasted 90 minutes with zero observations. Periodic review time fell from 11 days to 2.
90 min
Inspection time
−82%
Periodic review
3×
Validation projects/y
Atlas Therapeutics
Contract manufacturer · Frankfurt, DE
Full migration in 11 days using the cGen wizard. Each sponsor now has a dedicated Inspector Mode portal with their records only. Two sponsor audits passed in the first quarter post-migration.
11 days
Migration time
100%
Records preserved
14
Sponsor portals
NovaCDMO
Pre-commercial biotech · Cambridge, UK
Validation completed in 5 weeks at one-quarter of the consultancy estimate using cGen + a single contract validation engineer. Commercial launch hit on schedule.
5 weeks
Time
−74%
Cost
0 days
Launch slip
Vivien Biotech
Cell & Gene Therapy · San Diego, CA
Custom CGT validation templates plus cGen AI risk assessor. Per-patient validation runs deterministically. Chain-of-identity and chain-of-custody captured automatically.
317
Patient batches validated
0
Chain-of-identity errors
<4 h
Release decision
Helix Cell Therapy
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